Study of Abdominal Aortic Aneurysm (a bulge in the aorta; known as AAA) repair.

What we are studying

You have been asked to consider participating in a clinical study because you have been diagnosed with an abdominal aortic aneurysm (a bulge in the aorta; known as AAA). The goal of this study is to evaluate the ongoing safety and effectiveness of the the AFX® System compared to other similar devices by collecting data on your condition and the devices. All of the devices that will be assessed in this study are approved by the FDA for the treatment of abdominal aortic aneurysms and are commercially available in the United States. The AFX®device is made by Endologix, Inc. and Endologix is the sponsor, that is, will be paying for the study. The other devices that will be used in the study are Gore® EXCLUDER® AAA Endoprosthesis, Medtronic The Endurant® II AAA Stent Graft System, and Cook Zenith Flex® AAA Endovascular Graft all of these devices are intended to be used for the treatment of abdominal aortic aneurysms.

Who is Eligible

Genders:

Men

Women

Races:

White

African American

Asian

American Indian or Alaska Native

Native Hawaiian or Pacific Islander

Other

All Ethnicities

Ages 18 - 90

Eligibility Criteria

Must have a minimum of 2 year life expectancy

Must have an infrarenal AAA who are assessed by the investigarot to be eligible for endovascular repair with the study devices.

What is involved

Follow-Up visits will include physical exams

Blood work

CT scans of abdomen and pelvis as standard of care after an AAA endovascular repair

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.